Summary
NextPoint Therapeutics is an exciting early-stage Boston-area startup company working at the frontier of immuno-oncology. We are currently looking to add a Clinical Development Leader to our fast moving, roll-up your sleeves team environment. Reporting to the Chief Medical Officer, the Clinical Development Leader will be responsible for the development and implementation of clinical/translational drug development programs in all therapeutic areas. The candidate will serve as a clinical team lead, helping clinical and translational operations to execute clinical and translational strategy and working closely with technical operations to help oversee all aspects of clinical programs. The candidate will collaborate closely with Research and Translational Sciences to develop and refine NextPoint’s clinical development strategy and drive its effective implementation to support our clinical programs.

Responsibilities

• Oversee implementation of clinical programs in line with the clinical and translational strategy and ensure patient safety and data integrity.
  
• Work closely with clinical research operation teams, translational operations, and CROs to build in scientific quality to clinical programs and protocols upfront including quality control programs. Lead and manage cross-functional efforts to achieve these goals.
  
• Work closely with site investigators; foster clinical and research collaborations with new and existing investigators to help execute on clinical programs.
  
• Lead the design, execution, analysis, interpretation, and reporting of clinical studies, both early and more advanced, in collaboration with R&D team members in a matrixed and highly collaborative team environment
  
• Lead development and implementation of program biomarker plans and ensure successful implementation at study site(s); work closely with Translational Operations and site investigators to ensure acquisition of meaningful datapoints for clinical trial interpretation.
  
• Act as medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates. Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies to inform clinical strategy
  
• Work closely with the R&D team to accumulate scientific and medical knowledge necessary to support clinical development plans, study designs, and protocols
  
• Monitor real time study data to ensure the integrity of the study and the study data and interact with investigators and internal and external experts to resolve any study issues
  
• Author or co-authors regulatory documents leading to IND filings, participates in regulatory meetings, and interactions as well as regulatory submissions (NDAs)
  
• Help to prepare manuscripts, abstracts, and presentations for scientific meetings and advisory boards
  
• Conduct literature reviews and prepare summaries to support clinical development programs, strategic initiatives, and potential clinical development strategies for preclinical programs
  
• Work collaboratively with discovery/early development to optimize innovations early in life cycle

Experience and Qualifications

• MD and/or Ph.D. in cancer biology, immunology, pharmacology, genomics, biochemistry, or molecular/cellular biology.
  
• 5+ years of relevant experience in biopharmaceutical industry or academic drug development including at least 3 years immuno-oncology experience.
  
• Oncology patient care experience preferred.
  
• Experience with translational assay development in oncology and/or immunology or immuno-oncology strongly preferred.
  
• Experience with conduct of global trials, particularly in Asia/South Korea preferred.
  
• Experience in working with CROs and clinical or translational operations to oversee clinical trial conduct.
  
• Extensive knowledge of clinical development, FDA and global clinical trial regulations, and ICH GCP guidelines
  
• Knowledge of biomarker and CDx regulations and experience in biomarker development strongly preferred.
  
• Passion and proficiency in developing and nurturing key partnerships and collaborations with external parties including investigators, KOLs, CROs, and the broader scientific community (including academia, governmental, or nonprofit organizations) as well as internal discovery and preclinical functions.
  
• Aptitude and interest in serving as a subject matter expert and mentor across the organization
  
• Excellent written and oral communication skills; experience delivering effective presentations to both technical and non-technical audiences
  
• Ability to balance multiple stakeholders and projects simultaneously, and able to operate with high accountability and under tight deadlines
  
• Strong solutions-oriented team player with excellent interpersonal skills
  
• Forward looking thinker, who actively seeks opportunities and proposes solutions with strong decision-making capability
  
• A collaborator who communicates in an open, clear, complete, timely and consistent manner, who listens effectively and invites response and discussion.